Lipitor Recall 2012: Glass Particles Found In Generic Versions

A Lipitor recall in 2012 on which we reported last week is still ongoing, leading to possible looming shortages of the blockbuster medication, and new reports indicate that glass particles found in some batches are the reason the product is being pulled.

The Lipitor recall in 2012 follows a recall of the drug in 2010, which was also due to product integrity. The Lipitor recall in that year, however, was due to a “musty smell,” an issue that affected drugs across several brands over a years-long span. Johnson & Johnson in particular was forced to pull several drugs from the market after the pervasive issue, attributed to a chemical in pallets called TBA, affected a broad spectrum of popular medications.

The Lipitor recall in 2012 involves a generic form of the hugely popular medication distributed by drug manufacturer Ranbaxy, and analysts say the potential glass-related adulteration could harm the maker’s credibility in US markets:

“The development will impact the company’s credibility to an extent. There have been issues in the past [about compliance] and a recall suggests, corrective measures suggested by the U.S. FDA are not being implemented.”

According to Fox News, the Lipitor recall of 2012 may lead to a shortage of atorvastatin, but the site says that Ranbaxy does not expect the recall due to glass particles to create a long-term Lipitor supply issue:

“Ranbaxy Laboratories Ltd. has recalled more than 40 lots of its generic version of the cholesterol-lowering drug Lipitor from the U.S. market after finding batches containing small glass particles … Ranbaxy, an Indian unit of Japan’s Daiichi Sankyo Co. said the voluntary action would cause a temporary supply disruption, but the company expects to complete an investigation of the matter within two weeks and resume shipments thereafter.”

The Food Drug Administration (FDA) says that no injuries and no deaths have been linked to the Lipitor recall in 2012.